HMPC Document on the systematic Review of Monographs Herbal Medicinal Products updated

Recommendation

23-25 April 2024
Barcelona, Spain

Global Registration and Life Cycle Management for APIs

On 28 January 2015 the EMA's HMPC (Committee on Herbal Medicinal Products) has updated the procedure which defines the systematic review of the monographs for herbal medicinal products of the European Union and the list entries of the European Union as well as their supporting documentation.

The legal basis for this is the EMA/HMPC reflection paper about the reasons and time periods for the revision of monographs and list entries. Every 5 years it has to be checked whether a monograph or a list entry is still up-to-date.

The HMPC review document deals with the following aspects:

• Scope of the revisions
• Timelines 
• Documentation of the review / revision

With regard to the last point it is mentioned that the extent of the changes made in each document must be transparent.

For more information please see the complete Rev 1 document  Procedure for the systematic review of European Union herbal monographs and/or European Union list entries and supporting documents.